The Fentanyl Sublingual Spray in Treating Patients With Breakthrough Cancer Pain trial in Woodlands, Texas is recruiting patients who are receiving opioids for cancer pain and/or as part of their mesothelioma treatment. The study’s primary objective is to determine the efficacy and safety of Fentanyl Sublingual (SL) spray for the treatment of breakthrough cancer pain in patients on around-the-clock opioids for persistent cancer pain.
The trial’s secondary goals are to evaluate the safety of Fentanyl SL spray in opioid-tolerant patients, as well as to assess participant satisfaction with the aforementioned treatment medication.
The study, which was last updated on ClinicalTrials.gov on April 27, 2010, has an estimated enrollment of 130 patients. The trial began in October, 2007 and has not yet been completed.
Opioid treatment is typically used in patients with moderate to severe cancer pain when milder medications, such as anti-inflammatory drugs, are ineffective in treating pain. This type of medication can often be administered to patients who have been diagnosed with any of several types of mesothelioma, including testicular mesothelioma.
Generally speaking, this cancer of the lining of the chest or abdomen is treated in mesothelioma clinics through surgery, radiation therapy, chemotherapy or a combination of the three. One such clinic, the Sloan-Kettering Mesothelioma clinic in NY, New York, is working to help patients suffering from the disease.
Both men and women ages 18 and older are welcome to participate in the Fentanyl Sublingual Spray trial, as long as they provide informed written consent. Recruits must be opioid-tolerant, and they must have undergone opioid treatment for at least 7 days. Patients must experience persistent pain related to their cancer in the 24 hours prior to assessment at the screening visit. They must also experience an average of 1-4 breakthrough cancer pains daily.
Patients must be able to evaluate pain relief and assess medical performance. Recruits may not be pregnant or nursing, and fertile patients must use birth control. If patients experience intolerable side effects to opioids or fentanyl participation is denied. Anyone with history of major organ system impairment or disease or uncontrolled hypertension is not eligible for participation. Patients who have suffered from transient ischemic attacks, neural vascular disease, stroke, or cerebral aneurysms over the last two years may not participate. Individuals with clinically uncontrolled sleep apnea are excluded from the trial, as are patients with painful erythema, edema or ulcers under the tongue.
During the trial, the study medication is administered under the tongue as a spray and can be easily self-administered by the patients. Thirty minutes after the administration of the medication, patients fill out a questionnaire that assesses their satisfaction with the treatment. Patients will be treated up to a total of 6-7 weeks.
For additional information, visit the National Cancer Institute’s web page summary on this trial:
http://www.cancer.gov/clinicaltrials/INSYS-INS-05-001.
For more information on the Sloan-Kettering Cancer Center, visit:
http://www.mskcc.org/mskcc/html/76954.cfm.
ClinicalTrials.gov trial identifier: NCT00538850
The Mesothelioma and Asbestos Awareness Center encourages patients with a new diagnosis of mesothelioma to speak with their physician about finding an applicable clinical trial.
